ACRP CCRC Exam Practice Questions with Answers 100% Pass

ACRP CCRC Exam Practice Questions with Answers 100% Pass What is the goal of a Confirmatory trial? -Answer-to provide firm evidence of efficacy or safety What is the goal of an Exploratory trial? -Answer-to help provide a basis for confirmatory trials When is a composite variable useful? -Answer-when a single variable cannot be selected from multiple measurements What does a global assessment variable measure? -Answer-the overall safety, overall efficacy, and/or overall usefulness of a treatment When would multiple primary variables be useful? -Answer-to cover a range of effects of therapies When are surrogate variables useful? -Answer-when direct assessment of the clinical benefit to the subject through observing actual efficacy is not practical What are ways to avoid bias? -Answer-blinding and randomization When would a parallel group design be useful? -Answer-when testing different treatments, doses, etc. Why would a crossover design be useful? -Answer-it reduces the number of subjects, assessments, etc. What does a factorial design examine? -Answer-the interaction between treatments (when treatments are likely to be used together); establishes the dose-response characteristics of the simultaneous use of treatments What are the benefits of a multicenter trial? -Answer-they are more efficient and provide a better basis for the subsequent generalization of findings What are superiority trials designed to show? -Answer-they establish efficacy What are equivalence or non-inferiority trials designed to show? -Answer-that the investigational product is equal or no worse than an active comparator What do dose-response relationship trials show? -Answer-they confirm efficacy, investigate the shape and location of the dose-response curve, estimate an appropriate starting dose, identify optimal strategies for individual dose adjustments, and determine the maximal dose beyond which additional benefit would be unlikely to occur What is a goal of a group sequential design? -Answer-to facilitate the conduct of interim analysis What are the standards for expedited reporting of ADRs? -Answer-ASAP, but no later than 7 days for fatal or life-threatening ADRs; no more than 15 days for all other serious, unexpected ADRs What is the patient population for Phase 1 trials? -Answer-healthy volunteers or certain types of patients (ex: mild hypertension) What are the important aspects involved in Phase 1 trials? -Answer-estimation of initial safety and tolerability, pharmacokinetics, assessment of pharmacodynamics, and early measurement of drug activity